ESD AqaNife 200.53.04

GUDID 04260206310419

The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thick tissue (needle length of 3.0 mm)

Ovesco Endoscopy AG

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• Primary Device ID: 04260206310419
• NIH Device Record Key: 8ddf53ea-3959-4478-bad2-7f8cf9e91a3a
• Commercial Distribution Discontinuation: 2018-11-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ESD AqaNife
• Version Model Number: 3.0 mm
• Catalog Number: 200.53.04
• Company DUNS: 344007369
• Company Name: Ovesco Endoscopy AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +19196519449
• Email: customerservice@ovesco-usa.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com
• Phone: +49707196528160
• Email: service@ovesco.com

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Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310419 [Previous]
GS1	04260206311065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141790

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-31
• Device Publish Date: 2016-09-16

On-Brand Devices [ESD AqaNife]

• 04260206310419: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes
• 04260206310402: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes
• 04260206310396: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes
• 04260206310389: The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes